NCT01871467已完成1 期
Sargramostim for Myeloid Dendritic Cell Deficiency - Phase I
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Target blood myeloid dendritic cell level of > 2.0 x 10<4>/mL
研究概览
简要总结
Previous studies have demonstrated a deficiency of blood dendritic cells in patients with kidney disease that is associated with the development of viral infections after kidney transplantation. We plan to test the ability of sargramostim to increase blood dendritic cell levels in patients with kidney disease in the hopes of developing new therapies to prevent viral infections after kidney transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years < 80 years with diagnosis of end stage renal disease and currently undergoing outpatient hemodialysis (HD) at one of the Johns Hopkins University-affiliated HD units
排除标准
- •Age<18or>80years
- •History of non-adherence to prescribed HD treatment
- •Active drug or heavy alcohol use (defined as > 4 drinks/day)
- •Pregnancy or breast feeding
- •Active infection (bacterial or viral) or clinically significant infections within the past three months (e.g. those requiring hospitalization, or as judged by the PI)
- •Active malignancy (with the exception of excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or adequately treated pre- invasive cervical cancer in situ)
- •Unstable cardiovascular status (angina, arrhythmias, congestive heart failure etc...)
- •History of liver disease (as defined by a diagnosis of uncompensated cirrhosis) • History of lung disease (including moderate-severe chronic obstructive pulmonary disease, interstitial lung disease, or asthma)
- •Known hypersensitivity to yeast-derived products
- •Hemoglobin < 10 g/dL and hematocrit < 30%.
- •Abnormal white blood cell (WBC) count at baseline (< 3 or > 12 x 10 cells/mm )
- •Treatment with WBC growth factors (G-CSF or GM-CSF) or immunosuppressive medications (tacrolimus, cyclosporine, mycophenolate, azathioprine, corticosteroids, chlorambucil, cyclophosphamide) within 4 weeks of study (erythropoiesis-stimulating agents will be allowed)
- •Treatment with lithium within 4 weeks of study
研究组 & 干预措施
Sargramostim administration
Experimental
Subjects will receive sargramostim.
干预措施: Sargramostim (Drug)
结局指标
主要结局
Target blood myeloid dendritic cell level of > 2.0 x 10<4>/mL
时间窗: 2-4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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